MODIFICATION TO: VELSCOPE

K070523 · Led Dental, Inc. · NXV · Apr 5, 2007 · Dental

Device Facts

• Record ID: K070523
• Device Name: MODIFICATION TO: VELSCOPE
• Applicant: Led Dental, Inc.
• Product Code: NXV · Dental
• Decision Date: Apr 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6350
• Device Class: Class 2

Intended Use

VELscope is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia. VELscope is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.

Device Story

VELscope is an oral examination light system; consists of a Light Source Unit (LSU) and viewing handpiece. Device emits blue light into oral cavity; excites natural tissue fluorescence. Healthy tissue appears bright green; suspicious/diseased tissue exhibits loss of fluorescence and appears dark. Used by dentists and surgeons in clinical settings as an adjunct to standard white-light examinations. Enables real-time visualization of occult mucosal abnormalities; assists surgeons in identifying diseased tissue margins for surgical excision. Benefits include improved detection of lesions not visible to naked eye; aids in surgical planning.

Clinical Evidence

Evidence based on peer-reviewed, published scientific studies. Studies demonstrate effectiveness of VELscope in detecting occult cancerous and dysplastic lesions and assisting oral surgeons in assessing the extent of diseased tissue around clinically apparent lesions to determine surgical margins.

Technological Characteristics

System comprises a Light Source Unit (LSU) and viewing handpiece. Operates via blue light excitation of oral tissue to induce natural fluorescence. Standalone device; non-invasive. No specific materials or software algorithms described.

Indications for Use

Indicated for use by dentists or healthcare providers as an adjunct to traditional incandescent light oral exams to visualize oral mucosal abnormalities, including oral cancer or premalignant dysplasia. Also indicated for use by surgeons to identify diseased tissue margins around clinically apparent lesions.

Regulatory Classification

Identification

An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.

Predicate Devices

• VELscope (K060920)

Submission Summary (Full Text)

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K070523

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## Section 5 - 510(k) Summary

APR 5 - 2007

Submitter's Name: David Morgan, PhD

- 201-15047 Marine Dr. Address: White Rock, BC V4B 1C5 Canada
Date of Submission: February 14 2007

Contact Person: David Morgan, PhD

E-mail: [e-mail]

[phone], ext. 262 Phone:

[phone] Fax:

Device Name: VELscope

Common Name: Oral Examination Light

Classification Name: Ultraviolet detector

Marketed Device of Equivalence: VELscope (K060920)

### Description of Device:

VELscope is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination.

The main components of VELscope are the Light Source Unit (LSU) and the viewing Handpiece. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, healthy tissue typically shows up as a brighter green color while suspicious tissue can cause a loss of fluorescence, which thus appears dark.

### Intended Use:

VELscope is intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia. VELscope excites the tissue with blue light and allows the direct visualization of the resulting natural tissue fluorescence. VELscope is complimentary to and is intended to be used in combination with a traditional oral mucosal examination with incandescent (white) light.

VELscope is further intended to be used by a surgeon adjunctively to his/her clinical assessment to help identify diseased tissue around a clinically apparent lesion and thus

Dated: 2/14/2007

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aid in determining the appropriate margin for surgical excision.

### Characteristics of VELscope compared to Predicate Device:

The VELscope System is substantially equivalent to the VELscope System already cleared under 510(k) - K060920.

As compared to the predicate device, the VELscope system now has expanded indications for use based on recently published clinical data in peer-reviewed publications. These indications:

- Explicitly state the possibility of helping detect oral cancer and dysplasia .
- . Explicitly state the possibility of helping detect mucosal abnormalities that may not be visible or apparent to the naked eye.
- Include a new indication for use by surgeons as an aid to identifying diseased . tissue around a clinically apparent lesion to help determine the appropriate margin for surgical excision.

#### Clinical Studies:

Peer-reviewed and published scientific studies provide evidence to support that:

- VELscope is effective in helping detect occult cancerous and dysplastic lesions .
- VELscope can help an oral surgeon assess the extent of occult diseased tissue . around a clinically apparent precancerous or cancerous lesion and thus aid in determining the appropriate margin for surgical excision.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features the department's name encircling a symbol. The symbol consists of a stylized representation of three human figures connected by flowing lines, suggesting unity and collaboration. The overall design is simple and professional, reflecting the department's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 5 - 2007

David C. Morgan, Ph.D. Senior Vice President LED Dental, Incorporated 201-15047 Marine Drive White Rock, British Columbia Canada V4B 1C5

Re: K070523

Trade/Device Name: VELscope Regulation Number: 872.6350 Regulation Name: Ultraviolet Detector Regulatory Class: II Product Code: NXV Dated: February 14, 2007 Received: February 23, 2007

Dear Dr. Marine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 -Dr. Marine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylia Y. Michaud Dins.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

VELscope Device Name:

Indications For Use:

VELscope is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia.

VELscope is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kee Muling fn MSR

ion of Anesthesiology, General Hospital,
cuon Control, Dental Devices

2(k) Number: K070523

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